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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01704716 |
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Date of registration:
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05/10/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)
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Scientific title:
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High Risk Neuroblastoma Study 1 of SIOP-Europe (SIOPEN) |
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Date of first enrolment:
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February 2002 |
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Target sample size:
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3300 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT01704716 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Austria
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Belgium
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Czech Republic
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Czechia
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Denmark
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France
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Greece
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Hungary
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Ireland
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Israel
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Italy
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Norway
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Poland
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Portugal
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Slovakia
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Slovenia
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Spain
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Sweden
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Switzerland
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United Kingdom
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Contacts
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Name:
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Ruth L Ladenstein, MD, MBA, cPM |
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Address:
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Telephone:
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0043140470 |
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Email:
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ruth.ladenstein@ccri.at |
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Affiliation:
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Name:
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Ruth L Ladenstein, MD, MBA, cPM |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Anna Kinderkrebsforschung |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- • Established diagnosis of neuroblastoma according to the International Neuroblastoma
Staging System (INSS).
- Age below 21 years.
- High risk neuroblastoma defined as either:
1. INSS stage 2, 3, 4, and 4s with MYCN amplification, or
2. INSS stage 4 without MYCN amplification aged > 12 months at diagnosis
- Patients who have received no previous chemotherapy except for one cycle of
etoposide and carboplatin (VP16/Carbo). In this situation patients will receive
Rapid COJEC induction and the first Rapid COJEC cycle may be replaced by the
first cycle VP16/Carbo (etoposide / carboplatin).
- Written informed consent, including agreement of parents or legal guardian for
minors, to enter a randomised study if the criteria for randomisation are met.
- Tumour cell material available for determination of biological prognostic
factors.
- Females of childbearing potential must have a negative pregnancy test. Patients
of childbearing potential must agree to use an effective birth control method.
Female patients who are lactating must agree to stop breast-feeding.
- Registration of all eligibility criteria with the data centre within 6 weeks from
diagnosis.
- Provisional follow up of 5 years.
- National and local ethical committee approval.
Exclusion Criteria:
Any negative answer concerning the inclusion criteria of the study
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Age minimum:
1 Month
Age maximum:
21 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neuroblastoma
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Intervention(s)
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Drug: Carboplatin
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Drug: Cyclophosphamide
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Drug: Cisplatin
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Drug: Vincristine
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Drug: Busulfan
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Drug: Etoposide
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Drug: G-CSF
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Drug: Aldesleukin
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Drug: Doxorubicin
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Drug: ch14.18/CHO
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Drug: Melphalan
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Primary Outcome(s)
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Event Free Survival (immunotherapy)
[Time Frame: Up to three years]
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Event free survival (R3: Induction therapy)
[Time Frame: Up to three years]
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Complete metastatic response (R3: Induction therapy)
[Time Frame: Up to 95 days]
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Event Free Survival (R1: MAT therapy)
[Time Frame: Up to three years]
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Secondary ID(s)
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HR-NBL-1.8 / SIOPEN
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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